Importance of Chain of Custody Documentation for Biologics

Preventing patients from receiving “counterfeit, diverted, sub-potent, substandard, adulterated, misbranded, or expired drugs” is a critical element of the mission of the US Food and Drug Administration (FDA). The protection of the pharmaceutical supply chain is one of the FDA’s highest priorities, and chain of custody is one of the FDA’s primary tools in this mission. Chain of custody, when correctly executed, allows determination of “who, what, and when” with a high level of confidence. For advanced therapies—those derived or generated through biotechnology—chain of custody not only includes verification of “who, what, and when,” but also “at what temperature.”

The Four Stages of Equipment Qualification

As discussed in my previous blog, qualification is the process of establishing documented evidence that a specific equipment, facility or system are fit and ready for their intended use. It establishes confidence that the equipment in a biorepository is capable of consistently operating within set limits and tolerances, and allows for conduction of tests to be performed on one element or component of the process to be validated against a specified outcome.

Now that we have a better understanding of the difference between Qualification and Validation, let’s expand our knowledge of the four equipment qualification stages.

The Importance of Freezer Qualification for Biologics

For those studying, manufacturing, or experimenting with delicate pharmaceuticals and biological samples, the importance of storage and accurate temperature monitoring is well known. From a qualification and validation perspective, the equipment and processes used for shipping, storing, and other services must comply with the products’ requirements throughout the chain of custody.

In this two part blog series I will convey the importance of qualifying the equipment and validating the processes through which your valuable biological material is managed.

Accidental Freezing of Vaccines

When discussing the impact of temperature on vaccines, heat is the better-known hazard. However, while the vaccine cold chain is a way to protect vaccines from inactivation associated with high temperatures, exposure to low temperatures can also result in potency losses. In a 2007 study, researchers found that vaccines were exposed to freezing temperatures in 14 to 35 percent of refrigerators or transport shipments. Thus, accidental freezing of vaccines poses a significant and growing threat to national immunization programs. And in locations where the equipment is not qualified or the process is not validated, the impact of environmental temperatures on the vaccines could be significant.

"Vaccine” and “Cold Chain” are Inseparable

Vaccines are back in the news, whether an Ebola vaccine or advocacy for vaccine use in general. This news focus is much needed, particularly to highlight the importance of safeguards surrounding cold chain in handling vaccines. As the Head of Metrology at Fisher BioServices, the one constant, central, critical, working variable in my life is maintaining materials at the correct temperature, from point A to point B, and effective vaccines require effective temperature control.

The Case for Qualification and Validation of Biological Material Storage and Transit Systems

How much is your lack of temperature control costing you? Too often vaccines and bio-therapeutics are destroyed because of improper storage and distribution. And lost inventory is only the beginning of the true cost of not maintaining cold chain. Meeting ever more stringent regulatory requirements will become more difficult without taking the steps needed to qualify or validate your storage and transit systems. If you get 99 percent of your cold chain right but miss on the final 1 percent, you still fail, especially where cell-based products are involved. And the reason is most likely excess complexity, which is especially true for managing newer biologics such as an autologous cell therapy that requires the patient's sample to formulate the final therapeutic agent.

“Cold Chain” refers to the undisrupted series of logistical activities (packaging, shipping, storage, distribution, handling) of products that must be maintained within a given temperature range. And as those of us in the biopharmaceutical industry know well, maintaining cold chain is critical to the integrity of biologically derived therapeutic products.